The FDA announced today that the diabetes drug Avandia will now carry a black box warning label on the packaging. The black box warning label will state that the risk of heart attack may increase from taking the drug. The FDA notes that the greater risk of a heart attack has not been confirmed by three other studies done on Avandia.
Despite this addition to Avandia’s black box — the FDA’s strongest form of warning — the GlaxoSmithKline drug, will remain on the market as safety assessments of the drug continue, according to an FDA press release. The previous upgraded warning, added to the class of diabetes drugs that includes Avandia Aug. 14, emphasized that these types of drugs could worsen heart failure.
GlaxoSmithKline, the manufacturer of Avandia, stands by their drug saying that it is a safe drug when used following all of the drug’s guidelines. The black box warning label is the strictest issued by the FDA.